Proposed indications Mucopolysaccharidosis type II (MPS II), also known as Hunter Syndrome FDA approval timeline April 5, 2026 (review extended) Breakthrough Therapy Fast Track Orphan Drug Priority...

Vanda Pharmaceuticals submitted the atypical antipsychotic agent milsaperidone to the FDA for the treatment of bipolar I disorder and schizophrenia. Milsaperidone is an active metabolite of Vanda’s...

Pipeline (late-stage development) NAME MANUFACTURER ROUTE OF ADMINISTRATION MECHANISM OF ACTION PROPOSED/STUDIED INDICATION STATUS Aurora-GT United IV Gene therapy; autologous endothelial...

Copy to clipboard Copied! September 27, 2024 At Prime Therapeutics (Prime), we have positioned ourselves to best prepare our clients to manage new drugs. Our clinical and trade relations teams keep...